NCT01088620暂停2 期
CHAMP - An Open-label, Randomised, Multicentre, Phase II Clinical Study of Panitumumab Plus Pemetrexed and Cisplatin (PemCisP) Versus PemCis in the First-line Treatment of Patients With Stage IIIB or IV Primary Nonsquamous Non-small Cell Lung Cancer, With Particular Regard to the KRAS Status
WiSP Wissenschaftlicher Service Pharma GmbH20 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 134
- 试验地点
- 20
- 主要终点
- Progression free survival rate at 6 months
研究概览
简要总结
The purpose of this trial is to estimate the therapeutic efficacy of the experimental targeted regimen including the EGFR antibody panitumumab (in combination with pemetrexed and cisplatin) in relation to the standard combination in patients with a KRAS wild-type stage IIIB or IV primary nonsquamous non-small cell lung cancer. It is expected that the progression free survival rate at 6 months is improved by the targeted regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of inoperable stage IIIB or IV primary pulmonary nonsquamous NSCLC (according to UICC staging valid until 2008)
- •Sufficient representative sample material for KRAS analysis
- •Wild-type KRAS
- •Informed consent of the patient
- •Aged at least 18 years
- •WHO Performance Status 0-2
- •At least one unidimensional, measurable tumour parameter according to RECIST
- •Life expectancy of al least 12 weeks
- •Adequate haematological, hepatic, renal and metabolic function parameters:
- •Leukocytes > 3000/mm³, ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, Creatinine clearance ≥ 50 ml/min and serum creatinine ≤ 1.5 x upper limit of normal
- •Bilirubin ≤ 1.5 x upper limit of normal, GOT-GPT ≤ 2.5 x upper limit of normal in absence of liver metastases, or ≤ 5 x upper limit of normal in presence of liver metastases, AP ≤ 5 x upper limit of normal
- •Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal
排除标准
- •Prior chemotherapy
- •Clinically manifest, uncontrolled brain metastases
- •Prior radiotherapy of the parameters to be measured
- •Peripheral neuropathy NCI grade > 1
- •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
- •Serious concurrent diseases.
- •Major surgery within the last 4 weeks before recruitment
- •On-treatment participation in a clinical study in the period 30 days prior to inclusion.
- •Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.
- •Ongoing or active infection, including active tuberculosis or known infection with human immunodeficiency virus.
- •Superior vena cava syndrome contraindicating hydration.
- •History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •Patient with mild to moderate renal insufficiency who are unable to interrupt salicylates (like aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDS) for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long-acting agents such as piroxicam). Exception: Low dose aspirin (acetyl salicylic acid) intake up to 150 mg per day is permitted without interruption.
- •Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures
- •Inability or unwillingness to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures
- •Prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
- •Known allergic reactions on study medication
研究组 & 干预措施
Panitumumab plus pemetrexed and cisplatin (PemCisP)
Experimental
干预措施: Panitumumab (Drug)
Panitumumab plus pemetrexed and cisplatin (PemCisP)
Experimental
干预措施: Pemetrexed (Drug)
Panitumumab plus pemetrexed and cisplatin (PemCisP)
Experimental
干预措施: Cisplatin (Drug)
Pemetrexed and cisplatin (PemCis)
Active Comparator
干预措施: Pemetrexed (Drug)
Pemetrexed and cisplatin (PemCis)
Active Comparator
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression free survival rate at 6 months
时间窗: 6 months
次要结局
- Determination of the tumour response(6 months)
- Duration of response(6 months)
- Overall survival(6 month)
- Adverse effects / toxicity(6 months)
- Quality of life assessment(6 months)
研究者
研究点 (20)
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